Clinical Biotechnician

PSC Biotech® Corporation; Cork; Vor Ort; EUR 32.000 - 45.000; Vollzeit

Zusammenfassung

PSC Biotech Corporation in Cork is hiring a Clinical Biotechnician Specialist to perform day-to-day activities within Cell Culture, Purification and Process Services within the Manufacturing Group. They will be responsible for ensuring the manufacturing team has a successful site startup, process validation and product launch activities.

Reporting to the Manufacturing Manager, duties include monitoring process performance, troubleshooting of DCS (DeltaV) and PLC systems, and ensuring compliance

Qualifikationen

• Bachelor's degree in a biotech-related field or equivalent experience.
• Hands-on experience with cell culture, purification, and manufacturing processes.
• Familiarity with GMP documentation and batch records.

Aufgaben

• Perform cell culture, purification or support operations within Manufacturing.
• Monitor and report process performance using statistical process control.
• Support commissioning and qualification activities.
• Prepare, update and execute Batch Records, SOPs and GMP documentation.
• Provide process and equipment training within Manufacturing.
• Troubleshoot process equipment and control systems (DCS/PLC).
• Author and resolve quality deviations within Manufacturing.
• Participate in cross-functional team initiatives and validation protocols.
• Demonstrate commitment to safety, environmental and regulatory compliance.
• Work flexible shift patterns to meet Manufacturing needs.

Kenntnisse

Cell culture

Process services

Statistical process control

GMP documentation

Six Sigma

Lean manufacturing

Safety & compliance

Ausbildung

Bachelor degree in Biotechnology or related field

Tools

DCS (DeltaV)

PLC control systems

Jobbeschreibung

Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

PSC Biotech is hiring a Clinical Biotechnician Specialist on behalf of one of our clients in Cork.

Reporting to the relevant Manufacturing Manager, the primary role of the Biotechnician is to perform day to day activities within Cell Culture, Purification and Process Services within the Manufacturing Group. They will be responsible for ensuring the manufacturing team has a successful site start up, process validation and product launch activities. Reporting to the relevant Manufacturing Manager, the primary role of the Biotechnician is to perform day to day activities within Cell Culture, Purification and Process Services within the Manufacturing Group. They will be responsible for ensuring the manufacturing team has a successful site start up, process validation and product launch activities. Main areas of responsibility:

• Performing, monitoring and troubleshooting of the cell culture, purification or support operations within Manufacturing.
• Monitoring and reporting of process performance using statistical process control.
• Support of Commissioning and Qualification activities.
• Preparation, updating and execution of Batch Records, SOPs and other GMP documentation.
• Provide process and equipment related training as required within the Manufacturing Department.
• Troubleshooting of process specific equipment.
• Troubleshooting of DCS (e.g. Delta V) and PLC control systems.
• Authoring, investigating and resolving quality deviations raised within the Manufacturing Department.
• Participate in/ Lead Cross Functional team initiatives when required.
• Participate in the execution of validation protocols.
• Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
• Completion of assigned tasks to support manufacture of quality biopharmaceuticals in accordance with cGMP and EHS requirements.
• Use Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
• Working flexible shift patterns to meet business needs and Manufacturing schedule

12 Month of Contract

Requirements

Should be proficient in the operation of all equipment used in the respective functional area of responsibility.

Education

Bachelor degree in Biotechnology, Chemical or Biochemical Engineering, Biochemistry or Bio-systems Engineering or related field or equivalent experience is preferred.